A Polypill Strategy to Improve Adherence: Results From the FOCUS Project

Adherence to evidence-based cardiovascular (CV) medications after an acute myocardial infarction (MI) is low after the first 6 months. The use of fixed-dose combinations (FDC) has been shown to improve treatment adherence and risk factor control. However, no previous randomized trial has analyzed th...

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Published in:Journal of the American College of Cardiology 2014-11, Vol.64 (20), p.2071-2082
Main Authors: CASTELLANO, José M, SANZ, Ginés, ARNAIZ, Joan Albert, VAREA, Sara, MARTINEZ, Felipe, LORENZATTI, Alberto, IMAZ, Iñaki, SANCHEZ-GOMEZ, Luis M, RONCAGLIONI, Maria Carla, BAVIERA, Marta, SMITH, Sidney C, TAUBERT, Kathryn, PENALVO, José L, POCOCK, Stuart, BROTONS, Carlos, FARKOUH, Michael E, FUSTER, Valentin, BANSILAL, Sameer, FERNANDEZ-ORTIZ, Antonio, ALVAREZ, Luz, GUZMAN, Luis, LINARES, Juan Carlos, GARCIA, Fernando, D'ANIELLO, Fabiana
Format: Article
Language:English
Subjects:
Aged
Biological and medical sciences
Cardiology. Vascular system
Cardiovascular Agents - administration & dosage
Cardiovascular Diseases - epidemiology
Cardiovascular Diseases - prevention & control
Cohort Studies
Cross-Sectional Studies
Drug Combinations
Female
Heart
Humans
Male
Medical sciences
Medication Adherence
Middle Aged
Myocardial Infarction - drug therapy
Myocardial Infarction - epidemiology
Prospective Studies
Secondary Prevention - methods
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Summary:Adherence to evidence-based cardiovascular (CV) medications after an acute myocardial infarction (MI) is low after the first 6 months. The use of fixed-dose combinations (FDC) has been shown to improve treatment adherence and risk factor control. However, no previous randomized trial has analyzed the impact of a polypill strategy on adherence in post-MI patients. The cross-sectional FOCUS (Fixed-Dose Combination Drug for Secondary Cardiovascular Prevention) study (Phase 1) aimed to elucidate factors that interfere with appropriate adherence to CV medications for secondary prevention after an acute MI. Additionally, 695 patients from Phase 1 were randomized into a controlled trial (Phase 2) to test the effect of a polypill (containing aspirin 100 mg, simvastatin 40 mg, and ramipril 2.5, 5, or 10 mg) compared with the 3 drugs given separately on adherence, blood pressure, and low-density lipoprotein cholesterol, as well as safety and tolerability over a period of 9 months of follow-up. In Phase 1, a 5-country cohort of 2,118 patients was analyzed. Patients were randomized to either the polypill or 3 drugs separately for Phase 2. Primary endpoint was adherence to the treatment measured at the final visit by the self-reported Morisky-Green questionnaire (MAQ) and pill count (patients had to meet both criteria for adherence at the in-person visit to be considered adherent). In Phase 1, overall CV medication adherence, defined as an MAQ score of 20, was 45.5%. In a multivariable regression model, the risk of being nonadherent (MAQ 
ISSN:0735-1097
1558-3597
DOI:10.1016/j.jacc.2014.08.021